RESULTS
Tventy-five patients (92% male, mean age 58.5±14.1 years) were implanted with the S-ICD device and the AAE using our combined approach. The most common high infective risk factors were diabetes requiring insulin treatment (80%) and CKD requiring hemodialysis (48%), with 7 (28%) patients presenting with more than 2 risk factors. More than half (56%) of the cohort had an underlying ischemic cardiomyopathy, with the overall left ventricular ejection fraction of the cohort resulting reduced (27.0 [25.0–35.0]). Table 1 lists baseline characteristics of the study cohort. All procedures were successful in deploying the combined system. Peri-procedural characteristics of the cohort are listed in Table 2
Patients were followed-up for a median of 21 [14–29] months and all patients included in the study cohort completed at least 1 year follow-up. A single mild early post-operative hematoma was observed in the entire cohort (in an anticoagulated patient), that was managed conservatively, with a spontaneous resolution. No major device related infections were observed within the first 12 post-procedural months. Only a single pocket device infection was observed over the entire follow-up (at eighteen months of follow-up from device implant), that was managed conservatively and solved with antibiotic therapy. All device reported correct function at all follow-up visits. During the entire follow-up, eight patients received appropriate S-ICD therapies. At last available follow-up, two inappropriate shocks were observed (n=1 T-wave oversensing; n=1 far field) and three patients died (n=2 terminal heart failure; n=1 active malignancy). Entire follow-up data were reported in Table 3.